Director of Quality Assurance - Global Distribution & Logistics.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

About the Role

Lead the Life Sciences Group, Global Distribution Quality Assurance network in establishing and implementing the Quality Management System (including medical device/IVD regulatory requirements and applicable standards; 21CFR Part 820 QSR, ISO 13485:2016, MDR/IVDR as well as RUO products) supporting the global distribution of products that include strict cold chain management controls.

Responsibilities

• Establish and enhance all aspects of the Quality Management System from strategic planning to hands-on implementation on topics such as Distribution Quality Assurance/Control, auditing, document management, CAPA resolution, etc.
• Provide strategic Quality leadership in future business growth and in the integration of any new site transfers.
• Innovate quality management processes to drive efficiencies in the distribution network through the application of artificial intelligence, machine learning, and other tools to support optimization of resources and minimize product supply disruption and unfavorable customer experiences.
• Ensure that the customer perspective is maintained as a priority in the work done every day.

Requirements

• Bachelor's Degree required, preferred in Engineering or Science
• Minimum of 10 years in a regulated medical device/pharma manufacturing company, including minimum of 5 years leading a quality organization responsible for QA/QC, CAPA, post-market surveillance and all facets of product quality and Production & Distribution controls.
• Demonstrate a working understanding of applicable global medical device regulations and standards, (21 CFR Part 820, ISO13485, EU 2017/745 MDR, risk management ISO14971, and other relevant global standards), design control principles.
• Champions Quality by Design through the application of Production & Distribution controls, statistical process control, practical process improvement and other tools which support QMS compliance and advancement.
• Knowledge of Production & Process controls or Distribution controls. Handling distribution issues impacting licensed medical devices, IVDs, chemicals, controlled substances
• Shipping qualification processes including packaging, cold chain management
• Knowledge of Risk Managing tools including application of these tools
• Financial acumen including AOP planning Knowledge

Qualifications

• Strong authentic people leadership skills
• Strong Continuous improvement and Problem-solving experience (Lean approach)
• Outstanding communication skills with an ability to influence on a global level
• Managerial courage and decisiveness
• Adaptable when priorities change
• Experience in distribution and transportation preferred

Skills

• Strong authentic people leadership skills
• Strong Continuous improvement and Problem-solving experience (Lean approach)
• Outstanding communication skills with an ability to influence on a global level
• Managerial courage and decisiveness
• Adaptable when priorities change

Benefits

Comprehensive Total Rewards package that includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retail and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards